Highly uniform spunbonded nonwoven fabrics

ABSTRACT

A catheter anchoring system, apparatus and method for securing a catheter to a patient&#39;s skin, having two flexible side members and a cross-member therebetween to which a retaining assembly is mounted. The retaining assembly may hold a catheter hub at an angle for patient comfort. Gripping tabs secure to each retaining assembly side are gripped while advancing a cannula guide needle into the patient&#39;s vein and while attaching the catheter hub to a medical accessory, such as intravenous (I.V.) tubing, for increased patient comfort, reduction of the risk in contamination and patient infection, and to more easily and quickly start an I.V.

TECHNICAL FIELD

The subject disclosure relates to catheter anchoring and supportingdevices, and more specifically relates to catheter anchoring system,apparatus and method characterized by a removably mountable anchoringdevice for receiving a catheter hub of a catheter assembly, such thatthe anchoring device may be used as a guide to insert a cannula guideneedle and associated cannula (e.g., intravenous cannula) of a catheterassembly into a patient's vein. Mounting the anchoring device to thepatient limits movement of the catheter assembly in relation to thepatient after cannula insertion. The anchoring device may dispose thecatheter cannula at a preferred angle in relation to the patient. Theanchoring device is shaped to facilitate asepsis when wrapped with anaseptic dressing. The subject disclosure is particularly relevant toaiding in the insertion of an intravenous (I.V.) cannula, increasingpatient comfort and safety, reducing the risk of I.V. sitecontamination, and reducing the risk of patient infection.

BACKGROUND ART

A variety of catheter anchoring and supporting devices are discussed inthe prior art. One example is a catheter anchoring and supporting devicewhich has two adhesive members connected by an adhesive bridge to securethe members in a doubled over form when the two main members are used toposition a catheter tube to a patient. Another example is catheteranchoring and supporting system that has an adhesively-attachablesingle-piece having two channels connected by a bridge, each channel forreceiving a tubular segment.

However, these catheter anchoring and supporting system and devices donot address the desirable feature of aiding in the insertion of acatheter cannula into a catheter insertion site (e.g., a vein) of apatient. These catheter anchoring and support systems do not receive thehub of a catheter. Further, these catheter tube holders do not provideadequate adhesion between the patient's skin and the catheter insertionsite to prevent a substantial displacement of the inserted cannula fromthe insertion site such as when any outward force is applied to thecatheter tubing when moving a patient or when a patient is moving thearea having the cannula inserted therein.

What is needed is an adhesively-attachable catheter anchoring apparatushaving two side members and a cross-member therebetween, thecross-member having a retaining assembly integrated therein forreceiving the catheter hub of a catheter assembly and for holding theassociated cannula guide needle and the surrounding cannula atapproximately a 3-degree angle (e.g., or any desired angle) and furtherhaving two vertically-oriented gripping tabs disposed on each side ofthe retaining assembly, to optionally be gripped while advancing thecatheter assembly in the direction to pierce the vein with the cannulaguide needle and to guide the cannula into a desired vein withoutrequiring operator contact with the cannula or cannula guide needle,thus reducing the risk of an operator contaminating the catheter,thereby reducing the risk of patient infection, while also makingstarting the I.V. easier and faster. The present catheter anchoringapparatus addresses the foregoing needs by providing anadhesively-attachable H-shaped catheter anchoring apparatus with twoside members and a cross-member there between, the cross-member having aretaining assembly integrated therein for receiving a catheter hub in aposition desirable for insertion and for assisting in the advancement ofa cannula guide needle into a patient's vein.

DISCLOSURE OF THE INVENTION

A simplified summary is provided herein to help enable a basic orgeneral understanding of various aspects of exemplary, non-limitingembodiments that follow in the more detailed description and theaccompanying drawings. This summary is not intended, however, as anextensive or exhaustive overview. Instead, the sole purpose of thissummary is to present some concepts related to some exemplarynon-limiting embodiments in a simplified form as a prelude to the moredetailed description of the various embodiments that follow.

An embodiment of the present catheter anchoring system, apparatus andmethod includes a rectangular first side member having an upper portion,a lower portion, an inner side, and an outer side. A rectangular secondside member is in a closely-spaced, parallel relation to the rectangularfirst side member. The second side member has a top portion, a bottomportion, an inner edge and an outer edge. A cross-member is locatedbetween the first side member and the second side member, such that theapparatus attains an H-shaped configuration. The cross-member issubstantially rectangular having a top side, a bottom side, an outerfirst edge, an outer second edge, a front edge, and a rear edge. Aretaining assembly is located on the cross-member with a longitudinallypositioned channel inside for removably securing a catheter hub. Whenthe apparatus is placed on a patient's arm, the retaining assembly has aright side and a left side. The retaining assembly is mounted to thecenter of the top side of the cross-member. A plurality of retainingfingers is mounted to the right side and the left side of a retainingassembly. A first gripping tab is mounted to the top side of thecross-member in vertical relation to it and between the retainingassembly right side and the outer first edge of the cross-member. Asecond gripping tab is mounted to the top side of the cross-member invertical orientation to the top side and between the retaining assemblyleft side and the outer second edge of the cross-member. A vertical tabis mounted to the top side of the cross-member. The first side memberand the second side member are in vertical orientation thereto andbetween the outer side of the first side member and the outer edge ofthe second side member. The vertical tab has a front face, a rear face,and a bottom edge surface. The bottom edge surface is connected to thetop side of the cross-member. The first side member and the second sidemember are in parallel relation to the front edge. Adhesive for anadhesive layer is bonded to a bottom surface of the apparatus. Theadhesive is selected from a class of adhesives that are suitable for useon human skin. A backing removably covers the adhesive layer. Accordingto an embodiment, the backing has additional, continuous backing that issubstantially the same size as the size of backing that removably coverthe adhesive layer. The additional backing is folded over the backing.The additional backing extends to the side of the catheter apparatusopposite the fold. A backing removal extension piece, that is attachedto the backing, extends beyond the catheter apparatus for removal of thebacking through the act of pulling the backing removal extension piece,the attached additional backing, and exposing the attached backing.

Another embodiment of the present catheter anchoring system, apparatusand method is provided to securely anchor a catheter to a site on apatient's skin. The device has a flexible, rectangular first side memberwith an upper portion, a lower portion, an inner side, and an outer sideand a flexible, rectangular second side member with a top portion, abottom portion, an inner edge, and an outer edge. The side members areadapted to be secured to the skin of a patient in closely-spaced,parallel relation. The device further features a rigid cross-memberhaving top side, a bottom side, an outer first edge, an outer secondedge, a front edge, and a rear edge. The outer first edge is affixed tothe center of the upper portion, near the inner side of the first sidemember and the second edge affixed to the center of the top portion,near the inner edge of the second side member. A retaining assembly hasa longitudinally disposed channel therein for removably securing acatheter adaptor. The retaining assembly is mounted to the center of thetop side of the cross-member. An indention in the rear edge of thecross-member is adjacent to the retaining assembly. The indention isconfigured to allow a catheter hub to be removably secured within thechannel. A first gripping tab is mounted to the top side of thecross-member in a vertical relation thereto and between the retainingassembly right side and the first edge of the cross-member. The firstgripping tab has a front side, a rear side, and a bottom edge. Thebottom edge is affixed to the top side of the cross-member in a parallelposition in relation to the front edge. A second gripping tab is mountedto the top side of the cross-member in vertical relation thereto andbetween the retaining assembly left side and the second edge of thecross-member. The second gripping tab has a front wall, a rear wall anda lower edge. The lower edge is affixed to the top side of thecross-member in a parallel position in relation to the front edge. Anadhesive layer is located on the lower portion of the first side member,on the bottom portion of the second side member, and on thecross-member. A backing removably covers the adhesive layer. The backingincludes a backing removal extension piece.

To use the present device, before insertion of the catheter, the hub ofthe catheter is snapped into the retaining assembly by the user, such asa nurse or physician. Then, gripping one of the tabs on either side ofthe retaining assembly, depending on the dominant hand of the user, thecatheter is advanced after locating and piercing the vein with a cannulaguide needle. Using the tabs to advance the catheter reduces the risk ofan operator contaminating the catheter and passing bacteria to thepatient because the operator's gloved fingers would not come into directcontact with the catheter itself or the cannula. Conventionally, a useruses a thumbnail to push on a ridge of the hub of the catheter therebymaking it very easy to contaminate the catheter by touching the catheter(e.g., cannula) before it enters the vein, which may occur even moreoften when the catheter operator has large fingers. After the catheteris in place, the operator holds one of the tabs while attaching, forexample, a saline lock or I.V. tubing with the other hand. The sidemembers and cross-member are then slightly lifted as the backing isremoved, and then the entire apparatus is pressed down to secure thedevice to a patient's skin. This device is much less cumbersome thansecuring a catheter into place with tape, particularly when the nurse orphysician is wearing gloves. In addition, the present device reduces apatient's pain when moving about because the catheter and I.V. do notpull at the site of the insertion.

As such, the general purpose of the improved catheter anchoring system,apparatus and method which has all of the advantages of the prior artmentioned heretofore and many novel features that result in an improvedcatheter anchoring system, apparatus and method which is notanticipated, rendered obvious, suggested, or even implied by the priorart, either alone or in combination thereof.

An object of the present catheter tube anchoring device to reduce therisk of contamination of a catheter through contact with non-sterilesurfaces, thereby reducing the risk of patient infection.

Another object of the present catheter tube anchoring device is to makethe starting of an I.V. much easier and faster than permitted by priorart devices.

Yet another object of the present catheter tube anchoring device is toeasily secure a catheter to a patient's skin.

Still further, another object of the present catheter tube anchoringdevice is to substantially immobilize the IV to the skin of a patient,thereby reducing pain caused by movement of the IV in relation to thepatient.

Thus has been broadly outlined the more important features of theimproved catheter tube anchoring device so that the detailed descriptionthereof that follows may be better understood and in order that thepresent contribution to the art may be better appreciated.

The above-described deficiencies of today's systems for catheteranchoring are merely intended to provide an overview of some of theproblems of conventional systems, and are not intended to be exhaustive.Other problems with the state of the art and corresponding benefits ofsome of the various non-limiting embodiments may become further apparentupon review of the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

Various non-limiting embodiments are further described with reference tothe accompanying drawings in which:

FIG. 1 is a schematic isometric top view of an embodiment of thecatheter anchoring system, apparatus and method, according to anembodiment.

FIG. 2 is a schematic perspective right side view of an embodiment ofthe present disclosure.

FIG. 3 is a schematic isometric bottom view of an embodiment.

FIG. 4 is a schematic isometric bottom view of an embodiment.

FIG. 5 is a schematic top view of an embodiment.

FIG. 6 is a schematic bottom view of an embodiment.

FIG. 7 is a schematic right side view of an embodiment.

FIG. 8 is a schematic front view of an embodiment.

FIG. 9 is a schematic back view of an embodiment.

FIG. 10 a is a schematic side view of a catheter hub according to anembodiment.

FIG. 10 b is a cross sectional view along the line 10 b-10 b of FIG. 9.

FIG. 11 is a schematic isometric top view of an embodiment having acatheter hub inserted therein.

FIG. 12 is a schematic perspective rear view of an embodiment having acatheter hub inserted therein.

FIG. 13 a is a schematic isometric top view of an embodiment containinga winged catheter hub attachment.

FIG. 13 b is a schematic perspective rear view of an embodimentcontaining a winged catheter hub attachment.

FIG. 13 c is a schematic top view of an embodiment containing a wingedcatheter hub attachment.

FIG. 14 is a schematic in-use drawing of a catheter hub and associatedcannula and need being snapped into an embodiment.

FIG. 15 is a schematic in-use drawing of a method for locating theneedle of a catheter on the surface of a patient's skin, according to anembodiment.

FIG. 16 is a schematic in-use drawing of a method for removing theneedle while advancing the cannula of the catheter into a patient'sskin, according to an embodiment.

FIG. 17 is a schematic in-use drawing of a method of attaching a medicalaccessory to the catheter hub, according to an embodiment.

FIG. 18 is a schematic in-use drawing of a method of attaching aproviding additional securement to an embodiment with the use ofadhesive medical strips.

FIG. 19 is a schematic top view of an embodiment additionally securedwith adhesive medical strips.

FIG. 20 is a schematic in-use drawing of an embodiment as it is securedto the skin with an adhesive backing, holding the cannula of a catheterhub in place with a medical accessory attached to the catheter hub.

FIG. 21 is a schematic front-right perspective view of an embodimenthaving an integrated catheter hub and a cannula extending therefrom.

FIG. 22 is a schematic rear-left perspective view of an embodiment.

FIG. 23 is a schematic top view of an embodiment.

FIG. 24 is a schematic bottom view of an embodiment.

FIG. 25 is an isometric top view of an embodiment.

FIG. 26 is an isometric bottom view of an embodiment.

FIG. 27 is a top plan view of an embodiment.

FIG. 28 is a cross-section view of an embodiment taken along line 4-4 ofFIG. 27.

FIG. 29 is an isometric in-use view of an embodiment.

FIG. 30 is an isometric top view of an embodiment.

FIG. 31 is an isometric bottom view of an embodiment.

BEST MODES FOR CARRYING OUT THE INVENTION AND INDUSTRIAL APPLICABILITYOverview

The claimed subject matter is now described with reference to thedrawings, wherein like reference numerals are used to refer to likeelements throughout. In the following description, for purposes ofexplanation, numerous specific details are set forth in order to providea thorough understanding of the claimed subject matter. It may beevident, however, that the claimed subject matter may be practicedwithout these specific details. In other instances, well-knownstructures and devices may be shown in block diagram form in order tofacilitate describing the claimed subject matter.

Moreover, the word “exemplary” is used herein to mean serving as anexample, instance, or illustration. Any aspect or design describedherein as “exemplary” is not necessarily to be construed as preferred oradvantageous over other aspects or designs. Rather, use of the wordexemplary is intended to present concepts in a concrete fashion. As usedin this application, the term “or” is intended to mean an inclusive “or”rather than an exclusive “or.” Therefore, unless specified otherwise, orclear from context, “X employs A or B” is intended to mean any of thenatural inclusive permutations. That is, if X employs A; X employs B; orX employs both A and B, then “X employs A or B” is satisfied under anyof the foregoing instances. In addition, the articles “a” and “an” asused in this application and the appended claims should generally beconstrued to mean “one or more” unless specified otherwise or clear fromcontext to be directed to a singular form.

With reference now to the drawings, and in particular FIGS. 1 through 31thereof, various embodiments employing the principles and concepts ofthe present catheter anchoring system, apparatus and method, generallydesignated by the reference number 10, will be described.

Referring to FIGS. 1 through 31, various embodiments of the presentcatheter anchoring system, apparatus and method 10 are used to secure acatheter assembly (e.g., including a cannula placed in the skin and amedical attachment such as intravenous tubing connected to a hub influid communication with said cannula) to a patient. The presentapparatus 10 provides a rectangular first side member 20, a rectangularsecond side member 40 in closely-spaced, parallel relation to the firstside member 20, and a cross-member 60 there between thereby forming anH-shaped configuration, according to some embodiments. It is recognizedby those skilled in the art that the cross-member 60 may be placed atany location along the parallel side members according to someembodiments. The first side member 20 has an upper portion 22, a lowerportion 24, inner side 26, and an outer side 28. The second side member40 has a top portion 42, a bottom portion 44, an inner edge 46, and anouter edge 48.

According to an embodiment shown in FIGS. 25 through 31, the generallyrectangular cross-member 60 has top side 62, a bottom side 64, an outerfirst edge 66, an outer second edge 68, a front edge 70, and a rear edge72. The outer first edge 66 is attached to the inner side 26 of thefirst side member 20. The outer second edge 68 is attached to the inneredge 46 of the second side member 40. According to an embodiment, theouter first edge 66 is attached at any point along the inner side 26 ofthe first side member 20, such that the cross-member 60 and the outerfirst edge 66 are in a substantially perpendicular configuration. Theouter second edge 68 is attached at any point along the inner edge 46 ofthe second side member 40, such that the cross-member 60 and the outersecond edge 68 are in a substantially perpendicular configuration.

According to an embodiment as shown in FIGS. 1 through 31, the presentapparatus is constructed from a single polymer having operationalelastomeric characteristics such that the apparatus is selectivelyflexible according to the type of polymer chosen. One application of aflexible apparatus is that a single design (e.g., an apparatusconfiguration of a single size) of the apparatus can adapt to (e.g.,fit) a greater percentage of patients' arms (e.g., appendages). Anotherapplication of a flexible apparatus is to increase usability insituations where a patient's skin may be very tender and sensitive tothe placement of rigid or ill-fitting medical devices on their body. Asubstantial benefit is realized by having the ability to change thecomposition of the polymer used as the substrate for the apparatus andas a result, directly change the operational elastomeric characteristicsof the apparatus as a whole. As might be expected, the possibleapplications of this ability are numerous. According to someembodiments, the use of more than one polymer is contemplated, forexample, for creating a soft surface to be placed against a patient'sskin and a rigid surface to receive the catheter hub. Other suchcombinations of more than one polymer are possible for a variety ofpurposes, but are not illustrated here.

Corners 128 (e.g., where edges of two side members meet) of the firstand second side members, according to an embodiment, are trimmed (e.g.,by filleting, chamfering or any other suitable technique) such that thecorners do not catch on dressings or other materials that might beplaced in contact with the first and second side members. The edges 129of the first and second side members, similarly, are ground down (e.g.,buffed, radiused) in order to reduce the sharpness of the edges, so thatthe edges to not catch on or damage dressings or other materials thatmight be placed in contact with the first and second side members.

The top or upper portions of an embodiment of the first or second sidemembers contains at least one longitudinally scored portion 120,parallel to a longitudinal edge (e.g., an edge that runs perpendicularto the cross-member), to increase flexibility of the primary supportstructure at that scored portion 120. According to an embodiment, twoscored portions 120 are employed such that one scored portion 120extends from the top portion of the first side member a distancedownwards into the first side member and the second scored portion 120extends from the upper portion of the second side member a distancedownwards into the second side member. The scored portions 120 aredisposed in a parallel configuration with each other and with alongitudinal edge of the first and second side members. The position,depth and number of the scored portions 120 is chosen to increase ordecrease lateral flexibility (e.g., flexibility along a line parallel tothe cross-member) of the first and second side members without modifyingthe polymer from which the apparatus is constructed. For example, thescored portions 120 may extend from a top portion downward into thefirst side member a distance of approximately 0.8 millimeters. Accordingto other embodiments, the range of the depth of the scored portions 120may range from 0 millimeters to 1.5 millimeters. According to an evenfurther embodiment, the range may be from 0.5 millimeters to 1millimeter. According to an even further embodiment, the range may befrom 0.7 millimeters to 0.9 millimeters. The scored portions 120 reducethe strength of the polymer at the scored portions 120, allowing theoutermost edges of the first and second side portions to be bendable(e.g., acting as wings that can be bent to conform to a patient's arm).One advantage of bending the first and second side portions might be tomore readily secure the assembly by surrounding an appendage of apatient with the retaining assembly 80.

According to an embodiment, a retaining assembly 80 having alongitudinally disposed channel 82 therein is configured to removablysecure a catheter hub 100 (e.g., catheter adaptor). The retainingassembly 80 is mounted to the center of the top side 62 of thecross-member 60. The retaining assembly 80 is attached to thecross-member 60 so that the catheter hub 100 is held at a 3-degree angle87 to increase patient comfort. According to various other embodiments,the retaining assembly 80 could hold the catheter hub 100 at any desiredangle in relation to the cross-member 60. According to furtherembodiments, the retaining assembly could hold a catheter hub of anydesired size.

According to an embodiment, the retaining assembly 80 has a right side84 and a left side 85. The position of the retaining assembly 80 in thecenter of the top side 62 of the cross-member 60 balances the retainingassembly 80 in a central position not only for patient comfort while thecatheter apparatus 10 is moved about, but also for aiding removal ofbacking 30 from an adhesive layer 99 to secure the apparatus 10 to apatient 200 without jarring the position of the catheter assembly, thusfurther increasing patient comfort. The adhesive for the adhesive layer99 is selected from a class of adhesives that are suitable for use onhuman skin. Various adhesives can be chosen for various embodimentsdepending on the degree of adhesion required and other factors (e.g.,type of skin to be used on, length of time the adhesive must remainadhered).

According to an embodiment, an indention 90 in the rear edge 72 of thecross-member 60 and adjacent to the retaining assembly 80 is optionallyconfigured to allow a catheter hub 100 to be removably secured withinthe channel 82. Optionally, an indention 90 increases the ease withwhich a catheter hub 100 is inserted into the retaining assembly 80.Insertion of a catheter hub 100 in to the retaining assembly 80 is aidedby the presence of the indention 90 in the cross-member 60 when comparedto a retaining assembly 80 affixed to a cross-member 60 without theindention 90.

According to an embodiment, the retaining assembly 80 has a plurality ofretaining fingers 110 that mount to the right side 84 and the left side85 of the retaining assembly 80. These retaining fingers 110 (e.g.,retaining members) may number four, and may be positioned at alongitudinal end of the retaining assembly 80. The retaining fingersextend away from the right side 84 and the left side 85 in a circularmanner, essentially “grabbing” a catheter hub 100 as it is inserted intothe retaining assembly 80, and acting to securing the catheter hub 100,preventing the catheter hub 100 from being removed from the retainingassembly 80.

According to an embodiment, a three-dimensional support structure 112surrounds, and is integrated (e.g., molded) or otherwise part of theretaining assembly 80. The support structure 112 includes asubstantially triangular, sloped element 114 integrated into both sidesof the retaining assembly 80 in order to integrate the retainingassembly 80 with the cross-member 60 and prevent it from moving inrelation to the catheter apparatus 10. In addition to physicallysupporting the retaining assembly 80, the sloped elements' primarysloped surface 116 is adapted to receive an adhesive backed surface ofaseptic tape or of an aseptic dressing, so that the adhesive backedsurface can be adhered (e.g., sealed) substantially continuously to thesloped surfaces, forming a shield between the surrounding environmentand the retaining assembly, preventing bacteria from reaching thecatheter insertion site.

According to an embodiment, a first gripping tab 50 is mounted to thetop side 62 of the cross-member 60 in vertical relation thereto andbetween the retaining assembly right side 84 and the outer first edge 66of the cross-member 60. The first gripping tab 50 has a front side 51, arear side 52 and a bottom edge 53. The bottom edge 53 is affixed to thetop side 62 of the cross-member 60 in parallel position in relation tothe front edge 70. A rigid second gripping tab 55 mounted to the topside 62 of the cross-member 60 in vertical relation thereto and betweenthe retaining assembly 80 left side 85 and the outer second edge 68 ofthe cross-member 60. The second gripping tab 55 has a front wall 56, arear wall 57, and a lower edge 58. The lower edge 58 is affixed to thetop side 62 of the cross-member 60 in parallel position in relation tothe front edge 70. The gripping tabs reduce the risk of contaminatingthe catheter by preventing direct contact of the operator's fingers withthe catheter itself. Thus, the risk of infecting a patient 200 ismitigated. The use of the gripping tabs 50, 55 for advancing thecatheter apparatus 10 and associated cannula guide needle 101 into thepatient's 200 vein reduces the likelihood of contamination and potentialfor patient infection. In an embodiment, each of the first gripping tab50 and the second gripping tab 55 have a triangular prism shape whichhas the same footprint as the preferred embodiment first gripping tab 50and the second gripping tab 55. In this embodiment each of the firstgripping tab 50 and the second gripping tab 55 have an internal cavity54 therein and a rectangular front side 51, 56 perpendicular to thecross-member 60, as shown in FIG. 6. During use the front side 51, 56 ofeach of the first and second gripping tabs 50, 55 faces the user.

According to an embodiment, a vertical tab 118 is mounted to the topside 62 of the cross-member 60, the first side member 20 and the secondside member 40, in vertical relation thereto, and between the outer side28 of the first side member and the outer edge 48 of the second sidemember. The vertical tab 118 has one or more longitudinally scoredportions 120, each perpendicular to the cross-member 60 and positionedadjacent to the scored portions 120 in the first side member 20 and thesecond side member 40. The width of the longitudinally scored portions120 matches the width of the scored portions 120 in the first sidemember 20 and the second side member 40. The vertical tab 118 isintegrally mounted around the retaining assembly 80 such that it doesnot interfere with access to the channel 82 of the retaining assembly80. The vertical tab 118 has a front face 122, a rear face 124, and abottom edge surface 126. The bottom edge surface 126 is affixed to thetop side 62 of the cross-member 60, the first side member 20 and thesecond side member 40 in parallel position in relation to the front edge70. The front face 122 of the vertical tab 118 is adapted to receive theadhesive backed surface of aseptic tape or of an aseptic dressing, sothat the adhesive backed surface can be adhered substantiallycontinuously to the vertical tab 118. Combined with the sloped elements114, a shield may be formed around the retaining assembly 80, preventingforeign particles (e.g., bacteria) from entering the catheter insertionsite, and also possibly preventing infection.

According to an embodiment, the vertical tab 118 also reduces the riskof contaminating the catheter hub 100 by preventing direct contact ofthe operator's fingers with the catheter hub 100 or catheter itself.Thus, the risk of infecting a patient 200 is reduced. The use of therear face 124 of the vertical tab 118 for advancing the cannula guideneedle 101 (e.g., placing an operator's fingers only on the rear face124 in order to advance the guide needle and surrounding cannula) intothe patient's 200 vein reduces the likelihood of contamination andpotential for patient 200 infection. Additionally, use of only the rearface 124 maintains the front face 122 in an aseptic condition for when adressing is placed over the retaining assembly 80.

An adhesive layer 99, shown in FIGS. 3, 8 and 26 according to anembodiment, is disposed on the lower portion 24 of the first side member20, on the bottom portion 44 of the second side member 40, and on thebottom side 64 of the cross-member 60, permits the apparatus 10 to besecured to a patient's skin more quickly and easily than securement withtape, although some embodiments, shown in FIGS. 18 and 19, employmedical tape strips to provide for further securement of the retainingassembly 80 once the adhesive layer is exposed. In an embodiment, abacking 30 may cover the adhesive layer 99 so that the catheterapparatus 10 can be positioned without exposing and seating the adhesivelayer 99. The backing 30 may be one continuous backing that is foldedover, such that the folded over portion extends to the side of thecatheter apparatus 10 opposite the folded over portion, where a backingremoval extension piece extends beyond the catheter apparatus 10 forremoval of the backing through the act of pulling the backing removalextension piece 35. In an embodiment, an absorbent pad 105, which isdisposed on the entire bottom side 64 of the cross-member 60, the firstside member 20 and the second side member 40, is substituted for theadhesive layer 99.

According to an embodiment, a pressure-released polymeradhesive-containing capsule 107 is disposed within the internal cavity54 of each of the first and second gripping tabs 50, 55. Each of thecapsules 107 has a diameter of approximately ⅛ inch. According to anembodiment, in use, when securing the alternative embodiment of theapparatus 10 to the patient, the user places pressure on the first andsecond gripping tabs 50, 55 to break open the capsules 107 therein andto release the polymer adhesive which passes through mesh openings 108disposed on an bottom edge 53 of each of the first and second grippingtabs 50, 55 to permeate the absorbent pad and then onto user's skin toadhere the apparatus 10 onto the patient's skin. Alternatively, thepolymer adhesive is released onto and through the absorbent pad 105 ontothe patient's skin and then combines with a second adhesive which hasalready been applied to the patient's skin, prior to the polymeradhesive, and the combination thereof secures the apparatus 10 onto thepatient's skin.

According to an embodiment, a backing 30, which removably covers theadhesive layer 99 has a rectangular first part 31, a rectangular secondpart 32, a L-shaped third part 33, and a L-shaped fourth part 34. Thefirst part 31, second part 32, third part 33, and fourth part 34, eachhaving a backing removal extension piece 35. In the alternativeembodiment, the backing 30 removably covers the absorbent pad 105.

According to an embodiment, an adhesive layer 99 is disposed on thelower portion 24 of the first side member 20, on the bottom portion 44of the second side member 40, and on the bottom side 64 of thecross-member 60. The adhesive layer 99 may be applied to the lowerportion 24, the bottom portion 44, or the bottom side 64 at separatetimes or at the same time. A backing 30 is disposed on the adhesivelayer 99 (e.g., the portion of the adhesive layer opposite the lowerportion 24, bottom portion 44, or bottom side 64) such that removal ofthe backing 30 will expose the adhesive layer 99, enabling an un-backedportion of the apparatus to be adhered to a surface. The backing 30 ofthe adhesive layer 99 may cover the entire adhesive layer 99 or bescored and separated into multiple portions for ease of de-backing whenthe apparatus is placed in close proximity to the surface of a patient'sskin. One or more backing removal extension pieces 35 of the backing 30may extend past an edge of the apparatus so that an operator can graspthe backing removal extension piece 35, and easily remove the backing 30from the adhesive layer 99 underneath.

According to an embodiment, a spring-loaded push-release button 110 isdisposed atop an attachment end of a plastic housing 112 into which thecannula guide needle 101 is retracted.

An embodiment that can be used with a catheter having wingedattachments, such as the BD Nexiva™ brand closed IV catheter system,commercially available from Beckton, Dickinson and Company of FranklinLakes, N.J., is shown in FIGS. 13 a through 13 c.

Operation, According to Various Embodiments

As shown in FIGS. 14 through 20, according to an embodiment, to use thepresent apparatus 10, an operator, such as a nurse or physician, beginsby placing a catheter hub 100 securely into the retaining assembly 80before inserting an attached cannula guide needle 101 into a patient.FIG. 9 shows a rear view of the catheter apparatus 10, and FIG. 10 bshows a cut-away view of FIG. 9, along the line 10-10. FIG. 10 a showsthe catheter hub and FIG. 10 b shows where the catheter hub 100 is to bereceived. FIG. 11 shows an example of one type of catheter hub that canbe secured by the catheter apparatus 10. FIGS. 12 and 14 shows that hubinserted into the retaining assembly of the catheter apparatus 10. Theoperator then proceeds by locating and piercing the patient's 200 veinwith a cannula guide needle 101 of the catheter hub 100. Then, grippingeither the first gripping tab 50 or second gripping tab 55, an operatoradvances the cannula guide needle 101 into a patient's 200 vein. Afterthe cannula guide needle and associated cannula is desirably insertedinto the vein, the operator grips either the first gripping tab 50 orsecond gripping tab 55, depending on the operator's dominant hand, whileattaching corresponding I.V. tubing with the operator's other hand.

According to an embodiment, to secure the apparatus 10 to the patient'sskin, the operator slightly lifts the cross-member 60 while removing thebacking 30 by pulling on the backing extension piece 35. After removingthe backing 30, the user presses down on the cross-member 60, first sidemember 20, and second side member 40 to secure the apparatus 10 to apatient 200.

According to an embodiment shown in FIGS. 14 through 20, a user selectsa site on the patient 200 for the site of the catheter (e.g., andcatheter apparatus 10) and prepares the site according to apredetermined procedure. A tourniquet is applied to the arm of thepatient 200 at a point above the IV insertion point. The catheter hub100 of an intravenous catheter (e.g., still attached to the I.V.starting device, such as a cannula guide needle 101) is placed into theretaining assembly 80 where it becomes removably attached to thecatheter apparatus 10. With the catheter apparatus 10 and catheter hub100 assembled, the vein is pierced with the cannula guide needle 101. Athumb and forefinger can then be used to grasp the vertical tab 118 oneither side of the catheter hub 100 so that a force in the direction ofthe vein can be applied to the catheter apparatus 10, causing thecatheter (e.g., the cannula of the catheter and the cannula guideneedle) to advance into the vein. At this point, the catheter assemblywill be resting on the skin of the patient. As the cannula guide needle101 is retracted, the catheter apparatus 10 is held in place by thevertical tab 118. Ancillary catheter tubing is then secured, and thetourniquet is removed from the arm of the patient 200. The catheterapparatus 10 is secured when the user pulls on the backing removalextension piece 35, uncovering the adhesive layer on the underside ofthe catheter apparatus 10, enabling the adhesive layer to come intocontact with the skin.

According to an embodiment, addition securement can be provided byplacing securement tape (e.g., steri-strips, medical tape strips) overthe apparatus 10 and the attached catheter hub 100. An example of onemethod of providing additional securement to the apparatus is shown inFIG. 19.

According to other embodiments, for securing the device to the patient'sskin, the user slightly lifts the cross-member 60 while removing thebacking 30 from the lower side 109 of the absorbent pad 105 by pullingon a corresponding extension piece. The user then places pressure on thefirst and second gripping tabs 50, 55 to break open the capsules 107 andto release the polymer adhesive through the mesh openings 108 topermeate the absorbent pad, and then onto to the user's skin to adherethe apparatus 10 onto the patient's skin. Alternatively, the polymeradhesive is released onto and through the absorbent pad 105 onto thepatient's skin and then combines with a second adhesive which hasalready been applied to the patient's skin, prior to the polymeradhesive, and the combination thereof secures the apparatus 10 onto thepatient's skin. To retract the cannula guide needle, the user pushes thespring-loaded push-release button 110 disposed atop an attachment end ofthe plastic housing 112 in some embodiments.

FIGS. 21 through 24 illustrate an embodiment in which the catheterapparatus 10 is an integrated part of a catheter, such that the catheterhub 100 is integrated into (e.g., molded into) the apparatus 10. Acannula is shown extending from an end of the catheter hub, ready forinsertion into a vein of a patient.

The word “exemplary” is used herein to mean serving as an example,instance, or illustration. For the avoidance of doubt, the subjectmatter disclosed herein is not limited by such examples. In addition,any aspect or design described herein as “exemplary” is not necessarilyto be construed as preferred or advantageous over other aspects ordesigns, nor is it meant to preclude equivalent exemplary structures andtechniques known to those of ordinary skill in the art. Furthermore, tothe extent that the terms “includes,” “has,” “contains,” and othersimilar words are used in either the detailed description or the claims,for the avoidance of doubt, such terms are intended to be inclusive in amanner similar to the term “comprising” as an open transition wordwithout precluding any additional or other elements.

In view of the exemplary apparatus and methods described supra,methodologies that may be implemented in accordance with the disclosedsubject matter will be better appreciated with reference to theflowcharts of the various figures. While for purposes of simplicity ofexplanation, the methodologies are shown and described as a series ofblocks, it is to be understood and appreciated that the claimed subjectmatter is not limited by the order of the blocks, as some blocks mayoccur in different orders and/or concurrently with other blocks fromwhat is depicted and described herein. Moreover, not all illustratedblocks may be required to implement the methodologies describedhereinafter.

While the various embodiments have been described in connection with thepreferred embodiments of the various figures, it is to be understoodthat other similar embodiments may be used or modifications andadditions may be made to the described embodiment for performing thesame function without deviating therefrom. Therefore, the presentinvention should not be limited to any single embodiment, but rathershould be construed in breadth and scope in accordance with the appendedclaims.

1. An article, comprising: a nonwoven fabric comprising a plurality ofcontinuous fibers; wherein each fiber of the plurality of continuousfibers comprises a single polymer, the single polymer comprises apolyester, and the continuous fibers are randomly thermally bondedthroughout the nonwoven substrate.
 2. An article, comprising: a nonwovenfabric comprising a plurality of fibers; wherein the nonwoven fabric hasa M-4 web uniformity index of at most about 600 and, when the nonwovenfabric has a unit weight of 34 gsm, the nonwoven fabric has a tensilestrength of at least about 10 pounds in a cross-machine direction asmeasured according to ASTM D4595-09.
 3. An article, comprising: anonwoven fabric comprising a plurality of spunbonded fibers; wherein thenonwoven fabric has a M-4 web uniformity index of at most about
 600. 4.An article, comprising: a nonwoven fabric comprising a plurality offibers; wherein, when the nonwoven fabric has a unit weight of 34 gsm,the nonwoven fabric has a tensile strength of at least about 10 poundsin a cross-machine direction as measured according to ASTM D4595-09; andwherein the fibers are randomly thermally bonded throughout the nonwovenfabric.
 5. The article of claim 3, wherein each fiber comprises a singlepolymer.
 6. The article of claim 4, wherein the single polymer comprisesa polyester.
 7. The article of claim 1, wherein the single polymer is apolyethylene terephthalate, a polybutylene terephthalate, apolytrimethylene terephthalate, a polyethylene naphthalate, apolyglycolide, a polylactide, a polycaprolactone, a polyethyleneadipate, a polyhydroxyalkanoate, or a copolymer thereof.
 8. The articleof claim 1, wherein the single polymer has an intrinsic viscosity of atleast about 0.5 dl/g and at most about 0.7 dl/g.
 9. (canceled)
 10. Thearticle of claim 1, wherein at least some of the fibers have a circularcross-section.
 11. The article of claim 10, wherein the circularcross-section has an average diameter of from about 6 μm to about 20 μm.12. The article of claim 1, wherein at least some of the fibers have atrilobal, quadrulobal, pentalobal, or octalobal cross-section.
 13. Thearticle of claim 12, wherein the cross-section has an average diameterof from about 1 μm to about 6 μm.
 14. The article of claim 2, whereinthe fibers are randomly bonded throughout the nonwoven substrate. 15.The article of claim 1, wherein, when the nonwoven fabric has a unitweight of 34 gsm, the nonwoven fabric has a tensile strength of at leastabout 10 pounds in a cross-machine direction as measured according toASTM D4595-09.
 16. The article of claim 1, wherein the nonwoven fabrichas a M-4 web uniformity index of at most about
 600. 17-22. (canceled)23. A product, comprising the article of claim 1, wherein the product isa membrane filtration medium.
 24. The product of claim 23, wherein theproduct is a reverse osmosis filtration medium.
 25. A method,comprising: extruding a composition containing a single polymer to forma plurality of unbonded continuous fibers, the single polymer comprisinga polyester; mechanically drawing the unbonded continuous fibers; andarea bonding the unbonded continuous fibers to form a nonwoven fabriccomprising a plurality of bonded continuous fibers.
 26. The method ofclaim 25, wherein the area bonding comprises through-air bonding theunbonded continuous fibers to form the nonwoven substrate.
 27. Themethod of claim 25, wherein the area bonding is carried out at atemperature of at least about 145° C. and at most about 250° C. 28.(canceled)
 29. The method of claim 25, wherein the mechanically drawingcomprises passing the unbonded continuous fibers through at least twodraw rolls to form oriented fibers.
 30. The method of claim 29, whereineach of the two draw rolls has a fiber speed of at least about 1,800meters per minute.
 31. The method of claim 25, wherein, after areabonding the unbonded continuous fibers, the method further comprisescalendering the nonwoven substrate to form a calendered product.
 32. Themethod of claim 31, wherein the calendering is carried out at atemperature of at least about 145° C. and at most about 215° C. 33-34.(canceled)
 35. The method of claim 25, wherein the bonded continuousfibers comprise spunbonded fibers.
 36. The article of claim 1, whereinthe continuous fibers are randomly thermally bonded by area bonding. 37.The article of claim 4, wherein the fibers are thermally bonded by areabonding.
 38. The article of claim 4, wherein the nonwoven fabric doesnot comprise a polymer having an intrinsic viscosity higher than about0.64 dl/g.
 39. An article, comprising: a nonwoven fabric comprising aplurality of continuous, spunbonded fibers; wherein each fiber of theplurality of continuous, spunbonded fibers comprises a single polymer,the single polymer comprises a polyester, and the continuous fibers arerandomly thermally bonded throughout the nonwoven substrate; wherein thenonwoven fabric has a M-4 web uniformity index of at most about 600 and,when the nonwoven fabric has a unit weight of 34 gsm, the nonwovenfabric has a tensile strength of at least about 10 pounds in across-machine direction as measured according to ASTM D4595-09.